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FDA Clears Oxford Gene Technology FISH Probes

NEW YORK (360Dx) – Oxford Gene Technology announced today the US Food and Drug Administration has granted de novo classification for eight of the company's Cytocell Aquarius Haematology fluorescence in situ hybridization probes for acute myeloid leukemia and myelodysplastic syndromes.

The probes reduce the level of validation needed in laboratories and provide accurate, easy-to-interpret detection of chromosomal rearrangements reported in AML and MDS, according to UK-based OGT.

In a statement Steve Chatters, director of medical affairs for OGT noted that the FDA de novo pathway requires extensive clinical and performance data from multiple sites, as well as evidence of the safety and effectiveness of the probes. "What this means for customers, particularly in the US, is a significant reduction in the validation burden and immediate access to a range of high-quality IVD probes covering a comprehensive set of rearrangements," he said.

The probes which received FDA clearance are the AML1/ETO (RUNX1/RUNX1T1) translocation, dual fusion; CBFβ (CBFB/MYH11 translocation, dual fusion; Del(5q) deletion; Del(7q) deletion; Del(20q) deletion; EVI1 (MECOM) breakapart; MLL (KMT2A) breakapart; and P53 (TP53) deletion.